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Innovative highlights of clinical drug trial design

Clinical trials serve as the gold standard to evaluate the efficacy and safety of tested drugs prior to marketing authorization. Nevertheless, there have been a few challenging issues well noted in traditional clinical trials such as tedious processing duration and escalating high costs among others...

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Detalles Bibliográficos
Autores principales: Chen, Daohong, Qi, Eric Yining
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7267803/
https://www.ncbi.nlm.nih.gov/pubmed/32504825
http://dx.doi.org/10.1016/j.trsl.2020.05.007
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author Chen, Daohong
Qi, Eric Yining
author_facet Chen, Daohong
Qi, Eric Yining
author_sort Chen, Daohong
collection PubMed
description Clinical trials serve as the gold standard to evaluate the efficacy and safety of tested drugs prior to marketing authorization. Nevertheless, there have been a few challenging issues well noted in traditional clinical trials such as tedious processing duration and escalating high costs among others. To improve the efficiency of clinical studies, a spectrum of expedited clinical trial modes has been designed, and selectively implemented in contemporary drug developing landscape. Herein this article presents an update on the innovated human trial designs that are corroborated through coming up with approval of notable therapeutic compounds for clinical utilization including delivery of several blockbuster products. It is intended to inspire clinical investigators and pharmaceutical development not only timely communicating with the regulatory agencies, but also insightful translating from cutting-edge scientific discoveries.
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spelling pubmed-72678032020-06-03 Innovative highlights of clinical drug trial design Chen, Daohong Qi, Eric Yining Transl Res Article Clinical trials serve as the gold standard to evaluate the efficacy and safety of tested drugs prior to marketing authorization. Nevertheless, there have been a few challenging issues well noted in traditional clinical trials such as tedious processing duration and escalating high costs among others. To improve the efficiency of clinical studies, a spectrum of expedited clinical trial modes has been designed, and selectively implemented in contemporary drug developing landscape. Herein this article presents an update on the innovated human trial designs that are corroborated through coming up with approval of notable therapeutic compounds for clinical utilization including delivery of several blockbuster products. It is intended to inspire clinical investigators and pharmaceutical development not only timely communicating with the regulatory agencies, but also insightful translating from cutting-edge scientific discoveries. Elsevier Inc. 2020-10 2020-06-03 /pmc/articles/PMC7267803/ /pubmed/32504825 http://dx.doi.org/10.1016/j.trsl.2020.05.007 Text en © 2020 Elsevier Inc. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Article
Chen, Daohong
Qi, Eric Yining
Innovative highlights of clinical drug trial design
title Innovative highlights of clinical drug trial design
title_full Innovative highlights of clinical drug trial design
title_fullStr Innovative highlights of clinical drug trial design
title_full_unstemmed Innovative highlights of clinical drug trial design
title_short Innovative highlights of clinical drug trial design
title_sort innovative highlights of clinical drug trial design
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7267803/
https://www.ncbi.nlm.nih.gov/pubmed/32504825
http://dx.doi.org/10.1016/j.trsl.2020.05.007
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